Pediatric Surgical ProceduresNCT06608485
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
An observational study of Pediatric Surgical Procedures and Adult Surgical Procedures, run by Ethicon Endo-Surgery at 7 sites in 3 countries.
Trial summary
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures. Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures
- What is being tested?
- HARMONIC 700 Shears
- Type of treatment
- Medical device
- How many people
- 173 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 23 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).
Who may be able to join
- Pediatric participants
- Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
- Less than 18 years of age at the time of procedure
- Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
Who cannot join
- Preoperative
- Physical or psychological condition which would impair study participation
- Participants of childbearing potential who are pregnant
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
- HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United Kingdom4 sites
Dorset County Hospital Nhs Foundation Trust
Dorchester, DT1 2JY
Western General Hospital
Edinburgh, EH4 2XU
Southampton General Hospital
Southampton, SO16 6YD
Yeovil District Hospital
Yeovil, BA214AT
United States2 sites
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Canada1 site
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
About this study
Official title: A Prospective, Single-Arm Multi-Center Study of the HARMONIC™ 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
- Conditions
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures
- Being tested
- HARMONIC 700 Shears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARMONIC 700 ShearsDevice
There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears) | This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery. Receives: Device: HARMONIC 700 Shears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example [e.g.], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.
Measured: Intraoperative
Number of Participants with Device-Related Adverse Events (AEs)
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
Measured: Up to approximately 1 year and 7 months
Secondary outcomes (1)
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm)
Number of vessel transections with achievement of Grade 3 or lower hemostasis for each vessel transection of diameter > 5 to 7 mm will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start23 Jan 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethicon Endo-Surgery, Inc. Clinical Trial, Study director, Ethicon Endo-Surgery, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608485
- Sponsor's protocol ID
- ENG202301
- Other IDs
- ENG202301
- Status last verified
- Nov 2026
- First submitted
- 19 Sep 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Multi-Center Study of the HARMONIC™ 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)
- ClinicalTrials.gov ID
- NCT06608485
- Acronym / sponsor ID
- ENG202301
- Conditions
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears) | – | Device: HARMONIC 700 ShearsThis prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery. |
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).
Key inclusion criteria (6 listed)
- Pediatric participants
- Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
- Less than 18 years of age at the time of procedure
- Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
Key exclusion criteria (5 listed)
- Preoperative
- Physical or psychological condition which would impair study participation
- Participants of childbearing potential who are pregnant
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
- HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HARMONIC 700 ShearsThere is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use. | Device | Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears) |
Primary outcome
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Time frame: Intraoperative
Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example [e.g.], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.
Number of Participants with Device-Related Adverse Events (AEs)
Time frame: Up to approximately 1 year and 7 months
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
1 secondary outcome
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm)
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethicon Endo-Surgery, Inc. Clinical Trial study director
Ethicon Endo-Surgery, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Surgical Procedures and Adult Surgical Procedures, run by Ethicon Endo-Surgery at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.